MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH CMF; PLATE, BONE

Model Number	SD980.020
Medical Device Problem Codes	Fracture (1260); Physical Property Issue (3008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of internal documentation is in progress.An updated report will be filed when the investigation has been completed.
Event or Problem Description
A patient specific plate was used to perform a mandible reconstruction.It was reported that the 3d printed plate for this case broke after 6 months.By then the reconstruction had already nicely healed, so the surgeon didn't consider it as a big issue and just took it out.
Additional Manufacturer Narrative
A review of the internal documentation did not show an anomaly or deviation.The device design met the surgeon's expectations and met specifications.A cause for this specific clinical event cannot be ascertained from the information provided.Should additional information become available and/or the device be returned for evaluation and an investigation result be available that changes this assessment, an amended medical device report will be filed.
Event or Problem Description
A patient specific plate was used to perform a mandible reconstruction.It was reported that the 3d printed plate for this case broke after 6 months.By then the reconstruction had already nicely healed so the surgeon didn't consider it as a big issue and just took it out.

• Brand Name: TRUMATCH CMF
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• MDR Report Key: 7524881
• Report Number: 3003998208-2018-00003
• Device Sequence Number: 1529072
• Product Code: JEY
• UDI-Device Identifier: 05420060380204
• UDI-Public: 05420060380204
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SD980.020
• Device Catalogue Number: SD980.020
• Device Lot Number: ME17IZUVAR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR